BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ISOLA(TM) SPINE SYSTEM--EYE ROD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFLATION/DEFLATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·December 3, 2010

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 14, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 3, 2014

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024